NCT00180011已完成2 期
Efficacy of Omalizumab as Add on Therapy for Minority Patients With Moderate to Severe Asthma
DiMango, Emily, M.D.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2005年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Asthma symptom utility index
研究概览
简要总结
This study will be a randomized, placebo controlled, double blind study to measure the safety and efficacy of a new, injectable asthma medication, omalizumab, in a group of minority with moderate to severe asthma who are not adequately controlled with use of inhaled or oral steroids. Primary endpont will be change in asthma symptom utility index. Secondary endpoints will be changes in asthma Quality of life, asthma exacerbation rate, and lung function over the 12 week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-30
- •Minority Patients
- •Moderate or Severe allergic asthma (as defined by the National Asthma Education and Prevention Guidelines(7)]. Allergic asthma will be defined as elevated IgE level (> 100 IU/ml) and skin test sensitivity to at least one common aeroallergen
- •asthma control score greater than 1.5 (5) at randomization visit with use of equivalent of at least 1000 mcg fluticasone daily or systemic steroid use
- •FEV1 50-90% predicted at screening and randomization visit
排除标准
- •Active smoking within one year and/or greater than 10-pack year history of smoking
- •Women of childbearing age must be using effective contraception
- •Malignancy diagnosed within the past 5 years
- •Underlying lung disease other than asthma
- •Inability to comply with study protocol
研究组 & 干预措施
omaluzimab
Experimental
干预措施: Omalizumab (Drug)
结局指标
主要结局
Asthma symptom utility index
时间窗: 6 months
次要结局
- Secondary endpoints will be changes in asthma Quality of Life, asthma exacerbation rate, and lung function over the 12 week treatmet period.(6 months)
研究者
Emily DiMango
Assistant Professor
DiMango, Emily, M.D.
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Study of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic BronchitisEosinophilic BronchitisSteroid and/or Prednisone Dependent AsthmaNCT02049294McMaster University11
已完成
3 期
Omalizumab in Patients With Moderate to Severe Persistent Allergic Asthma Not Adequately Controlled Despite GINA (2009) Step 4 TherapyPersistent Allergic AsthmaNCT01202903Novartis Pharmaceuticals616
已完成
2 期
Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic UrticariaChronic UrticariaNCT00481676Novartis49
已完成
3 期
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal PolypsNasal PolypsChronic RhinosinusitisNCT03280550Hoffmann-La Roche138
已完成
3 期
A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal PolypsNasal PolypsChronic RhinosinusitisNCT03280537Hoffmann-La Roche127